Sickle Cell Reagent Set
FDA 510(k) K842368 · Livonia Diagnostics, Inc.
510(k) numberK842368
Submission
- Device name
- Sickle Cell Reagent Set
- Applicant
- Livonia Diagnostics, Inc.
Mchenry, IL, US - Received
- June 15, 1984
- Decision date
- July 20, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GHM – Test, Sickle Cell
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7825
- Specialty
- Hematology
Other 510(k)s with product code GHM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023656 | Sickle-Chex Solubility KitGHM · Traditional | Streck Laboratories, Inc. | 12/30/2002SE |
| K013316 | Sickle-ChexGHM · Traditional | Streck Laboratories, Inc. | 11/06/2001SE |
| K960947 | SAS Sickle Cell TestGHM · Traditional | Sa Scientific, Inc. | 07/01/1996SE |
| K911981 | Hemocard Hemoglobin SGHM · Traditional | Isolab, Inc. | 10/09/1991SE |
| K910430 | Hemocard-AsGHM · Traditional | Isolab, Inc. | 04/15/1991SE |
| K872217 | Thromboscreen Joshua Hemoglobin S Screening KitGHM · Traditional | Pacific Hemostasis | 07/31/1987SE |
| K860812 | Sickle Cell Reagent SetGHM · Traditional | Michclone Associates, Inc. | 04/11/1986SE |
| K860420 | Sickle Cell Reagent SetGHM · Traditional | Sterling Diagnostics, Inc. | 02/24/1986SE |
| K854079 | Thrombo Screen Sickle Cell Assay SetGHM · Traditional | Pacific Hemostasis | 10/31/1985SE |
| K842152 | Sickling Hemoglobin Controls, NormalGHM · Traditional | Isolab, Inc. | 09/09/1984SE |
More from Isolab, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K852161 | Serum Iron/Vibc Reagent SetJIY · Traditional | 06/10/1985SE |
| K844322 | Sgot Reagent SetCIQ · Traditional | 11/27/1984SE |
| K844283 | SGPT Reagent SetCKD · Traditional | 11/27/1984SE |
| K844237 | Alkaline Phosphatase Reagent SetCIO · Traditional | 11/20/1984SE |
| K844156 | Urea Nitrogen Reagent SetCDW · Traditional | 11/13/1984SE |
| K844182 | Inorganic Phosphorus Reagent SetCEO · Traditional | 11/09/1984SE |
| K843894 | HDL Precipatating Reagent SetLBR · Traditional | 11/02/1984SE |
| K844075 | Uric Acid Reagent SetLFQ · Traditional | 10/30/1984SE |
| K844024 | Creatinine Reagent SetCGX · Traditional | 10/30/1984SE |
| K843895 | Total Calcium Reagent SetCIC · Traditional | 10/30/1984SE |
Questions and answers
When was Sickle Cell Reagent Set cleared by the FDA?
Sickle Cell Reagent Set (K842368) received a 510(k) decision of Substantially Equivalent on July 20, 1984, 35 days after the submission was received.
What is the product code of K842368?
The FDA product code is GHM – Test, Sickle Cell, a Class II (moderate risk) device regulated under 21 CFR 864.7825.